U.S. patent number 11,045,106 [Application Number 16/761,200] was granted by the patent office on 2021-06-29 for system and method for detecting and diagnosing diseases and use of same.
This patent grant is currently assigned to THERMOVISIONUSA, INC.. The grantee listed for this patent is ThermovisionUSA, Inc.. Invention is credited to Robert C. Allison, Julius Chin-Hong Shu.
United States Patent |
11,045,106 |
Shu , et al. |
June 29, 2021 |
System and method for detecting and diagnosing diseases and use of
same
Abstract
A system and method for detecting disease comprising a device
for detecting angiogenesis and an electronic device. The device
comprises two microwave scanners, at least one multiple channel
radiometer, a microwave switch network, a controller, a data
transmission device, and a power source. Each microwave scanner
comprises a cup; a flexible printed circuit board, each circuit
board comprising: a plurality of antenna modules coupled thereto,
each antenna module comprising: an antenna, a multi-throw microwave
switch, and a temperature sensor. The antenna is configured to
receive microwaves thermal radiation from patient tissue and the
radiometer is configured to measure microwaves thermal radiation
emitted from patient tissue. The data transmission device is
configured to wirelessly transmit measurement data collected by the
controller from the radiometer and the temperature sensors to an
electronic device and the electronic device is configured to
transmit the measurement data to a cloud data storage.
Inventors: |
Shu; Julius Chin-Hong
(Torrance, CA), Allison; Robert C. (Torrance, CA) |
Applicant: |
Name |
City |
State |
Country |
Type |
ThermovisionUSA, Inc. |
Torrance |
CA |
US |
|
|
Assignee: |
THERMOVISIONUSA, INC.
(Torrance, CA)
|
Family
ID: |
1000005643576 |
Appl.
No.: |
16/761,200 |
Filed: |
October 22, 2019 |
PCT
Filed: |
October 22, 2019 |
PCT No.: |
PCT/US2019/057445 |
371(c)(1),(2),(4) Date: |
May 01, 2020 |
PCT
Pub. No.: |
WO2020/086586 |
PCT
Pub. Date: |
April 30, 2020 |
Prior Publication Data
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|
|
Document
Identifier |
Publication Date |
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US 20200289020 A1 |
Sep 17, 2020 |
|
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
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62748927 |
Oct 22, 2018 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B
5/0507 (20130101); A61B 5/6804 (20130101); A61B
5/0022 (20130101); A61B 2562/0271 (20130101); A61B
2560/0214 (20130101); A61B 2562/166 (20130101) |
Current International
Class: |
A61B
5/0507 (20210101); A61B 5/00 (20060101) |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
PCT/US/2019/57445; International Search Report and Written Opinion
dated Jan. 14, 2020. 17 pages. cited by applicant.
|
Primary Examiner: Wilson; Kaylee R
Assistant Examiner: Shah; Jay B
Attorney, Agent or Firm: Cislo & Thomas, LLP Sales;
Katherine B.
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATION
This application claims priority to and is a national phase entry
of International Application No. PCT/US 19/57445, entitled "System
and Method for Detecting and Diagnosing Diseases and Use of Same,"
filed Oct. 22, 2019, which claims the benefit of U.S. Provisional
Application No. 62/748,927, entitled "AIM Eco-system of Cyber
Tele-Healthcare for Breast Wellness and Disease Screening," filed
Oct. 22, 2018, which applications are incorporated in their
entirety herein by this reference.
Claims
What is claimed is:
1. A system for detecting disease, the system comprising: a) a
device for detecting angiogenesis, the device comprising: i) two
microwave scanners, each microwave scanner comprising: 1) a cup: 2)
a flexible printed circuit board coupled to the cup, each circuit
board comprising: a) a plurality of antenna modules coupled
thereto, each antenna module comprising: i. an antenna configured
to receive microwaves from patient tissue; ii. at least one
multi-throw microwave switch coupled to the antenna; and iii. at
least one temperature sensor located in close proximity to each
antenna configured to take temperature measurements; ii) at least
one multiple channel radiometer coupled to the plurality of antenna
modules by at least one coaxial cable, the radiometer configured to
convert the measured microwaves emitted from patient tissue into
measurement data; iii) at least one microwave switch network
coupled to the multi-throw microwave switch configured to perform a
switching sequence; iv) at least one controller electrically
coupled to both microwave scanners and configured to: 1) command
both the microwave switch switching sequence and the sequence of
the temperature sensor measurements; and 2) collect measurement
data from the radiometer and the temperature sensors used for
detecting angiogenesis; v) at least one data transmission device
electrically coupled to the controller and configured to wirelessly
transmit the measurement data collected by the controller from the
radiometer and the temperature sensors to an electronic device; and
vi) at least one power source comprising at least one rechargeable
battery; and b) an electronic device comprising a smart phone,
tablet, or computer, the electronic device configured to receive
the measurement data from the data transmission device and transmit
the measurement data to and receive processed data from a cloud
data storage.
2. The system of claim 1, further comprising a cloud data storage
configured to the measurement data from the electronic device.
3. A device for detecting angiogenesis, the device comprising: a)
two microwave scanners, each microwave scanner comprising: i) a
flexible printed circuit board comprising: 1) a plurality of
antenna modules coupled thereto, each antenna module comprising: a)
an antenna configured to receive microwaves from patient tissue; b)
at least one multi-throw microwave switch coupled to the antenna;
and c) at least one temperature sensor located in close proximity
to each antenna configured to take temperature measurements; ii) at
least one multiple channel radiometer coupled to the plurality of
antenna modules by at least one coaxial cable, the radiometer
configured to convert the measured microwaves emitted from patient
tissue into measurement data; iii) at least one microwave switching
network coupled to the multi-throw microwave switch and the
radiometer configured to perform a switching sequence; and b) at
least one controller electrically coupled to both microwave
scanners and configured to: i) command both the microwave switch
switching sequence and the sequence of the temperature sensor
measurements; and ii) collect measurement data from the radiometer
and the temperature sensors used for detecting angiogenesis; c) at
least one data transmission device electrically coupled to the
controller and configured to wirelessly transmit the measurement
data collected by the controller from the radiometer and the
temperature sensors to an electronic device; and d) at least one
power source comprising at least one rechargeable battery.
4. The device of claim 3, wherein the microwave scanner further
comprises at least one cup and the at least one flexible printed
circuit board is coupled to the at least one cup.
5. The device of claim 3, wherein the device is a garment with two
cups and the microwave scanners are coupled to the cups.
6. The device of claim 5, wherein the garment cups comprises at
least one piece of electrically conductive cloth.
7. The device of claim 5, wherein the garment is in the form of a
bra.
8. A device for detecting angiogenesis, the device comprising: a)
at least one microwave scanner, the microwave scanner comprising:
i) a flexible printed circuit board comprising: 1) a plurality of
antenna modules coupled thereto, each antenna module comprising: a)
an antenna configured to receive microwaves from patient tissue; b)
at least one multi-throw microwave switch coupled to the antenna;
and c) at least one temperature sensor located in close proximity
to each antenna configured to take temperature measurements; b) at
least one controller electrically coupled to the at least one
microwave scanner and configured to: i) command both the microwave
switch switching sequence and the sequence of the temperature
sensor measurements; and ii) collect measurement data from the
radiometer and the temperature sensors used to detect angiogenesis;
c) at least one data transmission device electrically coupled to
the controller and configured to wirelessly transmit the
measurement data collected by the controller from the radiometer
and the temperature sensors to an electronic device; and d) at
least one power source.
9. The device of claim 8, wherein the microwave scanner further
comprises at least one cup and the at least one flexible printed
circuit board is coupled to the at least one cup.
10. The device of claim 8, wherein the device is a garment with two
cups and each flexible printed circuit board is coupled to a
cup.
11. The device of claim 9, wherein the cups comprises at east one
piece of electrically conductive cloth.
12. The device of claim 10, wherein the garment is in the form of a
bra.
13. The device of claim 8, wherein the power source comprises one
of the following: a power cord or at least one rechargeable
battery.
14. A method of using the device of claim 3, the method comprising
the steps of: a) providing the device; b) placing the device on a
user's skin; c) scanning a user's subcutaneous tissue to produce
measurement data from the radiometers and temperature sensors; d)
transmitting the measurement data from the device to an electronic
device; and e) transmitting the measurement data from the
electronic device to a cloud data storage.
15. The method of claim 14, further comprising step f) after step
e), processing the measurement data to determine suspicious sites
in the user's tissue.
16. A method of using the device of claim 3, the method comprising
the steps of: a) providing the device; b) placing the device on a
user's skin; c) scanning a user's subcutaneous tissue to produce
measurement data from the radiometers and temperature sensors; and
d) transmitting the measurement data from the device to a cloud
data storage.
17. The method of claim 16, further comprising step e) after step
d), processing the measurement data to determine suspicious sites
in the user's tissue.
Description
BACKGROUND OF THE INVENTION
After a cell mutates into a cancer cell, the human body triggers
the process of angiogenesis, where the human body will naturally
raise the temperature of the cancer cell to a degree that is higher
than the surrounding healthy cells in an effort to provide
nutrition for the high metabolism activity of cancer cells.
Angiogenesis is not limited to cancer and is a process that the
human body undergoes in response to many different diseases. This
increase in cell temperature is called a thermal biomarker.
Properly designed microwave scanners containing an antenna, a
radiometer and related electronic devices can spot and detect the
thermal biomarkers, however, they are unable to differentiate
between the human body's response to different diseases, namely the
"heat source" that causes the existence of the detected thermal
biomarker.
As such, there is a need for an improved system and method for
detecting and diagnosing diseases.
The present invention overcomes several of the deficiencies,
disadvantages and undesired parameters associated with known
systems and methods for detecting and diagnosing diseases.
SUMMARY OF THE INVENTION
According to one embodiment of the present invention, there is
provided a system for detecting disease, the system comprising a
device for detecting angiogenesis and an electronic device
comprising a smart phone, tablet, or computer.
The device for detecting angiogenesis comprises two microwave
scanners, at least one multiple channel radiometer, at least one
microwave switch network, at least one controller electrically
coupled to both microwave scanners, at least one data transmission
device electrically coupled to the controller, and at least one
power source.
Each microwave scanner comprises a cup, a flexible printed circuit
board coupled to the cup, each circuit board comprising a plurality
of antenna modules coupled thereto, each antenna module comprising
an antenna configured to receive microwaves from patient tissue; at
least one multi-throw microwave switch coupled to the antenna; and
at least one temperature sensor located in close proximity to each
antenna configured to take temperature measurements.
The radiometer is coupled to the plurality of antenna modules by
coaxial cable and is configured to measure microwaves emitted from
a patient's internal tissue.
The microwave switch network is coupled to the multi-throw
microwave switch and is configured to perform a switching
sequence.
The controller is configured to command both the microwave switch
switching sequence and the sequence of the temperature sensor
measurements; and collect measurement data from the radiometer and
the temperature sensors.
The data transmission device is configured to wirelessly transmit
the measurement data collected by the controller from the
radiometer and the temperature sensors to the electronic
device.
The power source comprises at least one rechargeable battery.
The electronic device is configured to receive the measurement data
from the data transmission device and transmit the measurement data
to a cloud data storage.
Optionally, the system can further comprise a cloud data storage
configured to the measurement data from the electronic device.
In another embodiment, the present invention comprises a device for
detecting angiogenesis, the device comprising: two microwave
scanners, each microwave scanner comprising: a flexible printed
circuit board comprising: a plurality of antenna modules coupled
thereto, each antenna module comprising: an antenna configured to
receive microwaves from patient internal tissue; at least one
multi-throw microwave switch coupled to the antenna; and at least
one temperature sensor located in close proximity to each antenna
configured to take temperature measurements; at least one multiple
channel radiometer coupled to the plurality of antenna modules by
coaxial cable configured to measure microwaves emitted from patient
tissue; at least one microwave switching network coupled to the
multi-throw microwave switch and the radiometer configured to
perform a switching sequence; and at least one controller
electrically coupled to both microwave scanners and configured to:
command both the microwave switch switching sequence and the
sequence of the temperature sensor measurements; and collect
measurement data from the radiometer and the temperature sensors;
at least one data transmission device electrically coupled to the
controller and configured to wirelessly transmit the measurement
data collected by the controller from the radiometer and the
temperature sensors to an electronic device; and at least one power
source comprising at least one rechargeable battery.
Optionally, the microwave scanner further comprises at least one
cup and the at least one flexible printed circuit board is coupled
to the at least one cup.
Optionally, the device is a garment with two cups and the microwave
scanners are coupled to the cups.
Optionally, the garment cups comprise at least one layer of
electrically conductive cloth.
Optionally, the garment is in the form of a bra.
In another embodiment, the present invention is directed to a
device for detecting angiogenesis, the device comprising: at least
one microwave scanner, the microwave scanner comprising: a flexible
printed circuit board comprising: a plurality of antenna modules
coupled thereto, each antenna module comprising: an antenna
configured to receive microwaves from internal patient tissue; at
least one multi-throw microwave switch coupled to the antenna; and
at least one temperature sensor located in close proximity to each
antenna configured to take temperature measurements; at least one
controller electrically coupled to the at least one microwave
scanner and configured to: command both the microwave switch
switching sequence and the sequence of the temperature sensor
measurements; and collect measurement data from the radiometer and
the temperature sensors; at least one data transmission device
electrically coupled to the controller and configured to wirelessly
transmit the measurement data collected by the controller from the
radiometer and the temperature sensors to an electronic device; and
at least one power source.
Optionally, the power source comprises a power cord.
In another embodiment, the present invention is directed to a
method of using the device. The method comprises the steps of:
a) providing the device;
b) placing the device on a user's skin;
c) scanning a user's subcutaneous tissue to produce measurement
data from the radiometers and temperature sensors;
d) transmitting the measurement data from the device to an
electronic device; and
e) transmitting the measurement data from the electronic device to
a cloud data storage.
Optionally, the method can further comprise step f) after step e),
processing the measurement data to determine suspicious sites in
the patients tissue.
DRAWINGS
These and other features, aspects and advantages of the present
invention will become better understood with reference to the
following description, appended claims, and accompanying drawings
where:
FIG. 1 is a schematic view of a system for detecting and
tele-diagnosing diseases having features of the present invention,
wherein a device for detecting disease is included therein;
FIG. 2 is a perspective view of the device of FIG. 1, where the
device can be seen within a garment;
FIG. 3 is an enlarged sectional view of the device of FIG. 2,
wherein a back surface of the microwave scanner cups has been
removed to show the internal components;
FIG. 4 is an exploded view of the microwave scanner cups of the
device, where a flexible circuit board can be seen;
FIG. 5 is a block diagram of the electronic process of the device
of FIG. 2;
FIG. 6 is a block diagram of a Multiple Antenna Multiple Radiometer
Type 1 microwave scanner configuration of the present
invention;
FIG. 7 is a block diagram of a dual Multiple Antenna Single
Radiometer Type 2 configuration of the present invention;
FIG. 8 is block diagram view of an antenna module of the present
invention;
FIG. 9 is a schematic of a radiometer front end of the present
invention;
FIG. 10 is a view of flow chart of a method of detecting disease
according to the present invention;
FIG. 11 is a view of flow chart of a method of using the device of
FIG. 2; and
FIG. 12 is a diagram depicting the breast cancer life cycle,
starting with cell mutation.
DETAILED DESCRIPTION OF THE INVENTION
The following discussion describes in detail one embodiment of the
present invention and several variations of that embodiment. This
discussion should not be construed, however, as limiting the
invention to those particular embodiments. Practitioners skilled in
the art will recognize numerous other embodiments as well.
Definitions
As used herein, the following terms and variations thereof have the
meanings given below, unless a different meaning is clearly
intended by the contest in which such term is used.
The terms "a," "an," and "the" and similar referents used herein
are to be construed to cover both the singular and the plural
unless their usage in context indicates otherwise.
As used in this disclosure, the term "comprise" and variations of
the term, such as "comprising" and "comprises," are not intended to
exclude other additives, components, integers ingredients or
steps.
The terms "couple," "coupled," "couples," and "coupling," refer to
connecting two or more elements or signals electrically,
mechanically, or otherwise. Two or more electrical elements may be
electrically coupled, but not mechanically or otherwise coupled;
two or more mechanical elements may be mechanically coupled, but
not electrically or otherwise coupled; two or more electrical
elements may be mechanically coupled, but not electrically or
otherwise coupled. Coupling (whether mechanical, electrical, or
otherwise) may be for any length of time, e.g., permanent,
semi-permanent, or only for an instant.
The Invention
The system 100 as discussed in this application is with respect to
detecting and diagnosing breast cancer, but the system 100 is not
limited to breast cancer. The system 100 can be adapted to detect
and diagnose many different types of diseases and the hardware can
be adapted as necessary to accommodate different parts of the human
body. Additionally, this system and method is not limited to use on
humans. The system and method can also be adapted for use on other
subjects, such as animals.
Referring now to FIG. 1, there is shown a system 100 for detecting
and diagnosing diseases. The system 100 comprises two main
components: hardware 200 and software 300, and the software 300 can
comprise an application that can be used in connection with at
least one electronic device 302. Several additional programs can
also be used to process and analyze the data and image
classification produced by use of the system 100. The electronic
device 302 may be a mobile device such as a tablet computer, mobile
computer or smartphone, but may also be embodied in any one of a
wide variety of wired and/or wireless computing devices, including
a wired desktop computer. FIG. 1 depicts the use of the device 200
and program and/or application 300 with a smartphone, tablet and
laptop computer 302. The electronic device 302 includes a
processing device (processor), input/output interfaces, a display,
a network interface, a memory, an operating system, and storage.
The electronic device 302 may also include a touchscreen user
interface for ease of use and a wireless device, such as Bluetooth,
communicating across a local data bus. The system 100 also
comprises cloud data storage 304.
The processing device may include any custom-made or commercially
available processor, a central processing unit (CPU), or an
auxiliary processor among several processors associated with the
electronic device, a semiconductor based microprocessor (in the
form of a microchip), a macroprocessor, one or more application
specific integrated circuits (ASICs), a plurality of suitably
configured digital logic gates, and other electrical configurations
comprising discrete elements both individually and in various
combinations to coordinate the overall operation of the system.
The memory can include any one of a combination of volatile memory
elements (e.g., random-access memory (RAM, such as DRAM, and SRAM,
etc.)) and nonvolatile memory elements. The memory typically
comprises native operating system, one or more native applications,
emulation systems, or emulated applications for any of a variety of
operating systems and/or emulated hardware platforms, emulated
operating systems, etc.
The invention may include application specific software 300, which
may comprise some or all the components of the electronic devices
302 and the cloud data storage 304. In accordance with such
embodiments, the components are stored in memory and executed by
the processing device. The system and method for detecting and
diagnosing disease may be resident in the memory of the electronic
device 303 and/or optionally the cloud data storage 304.
One of ordinary skill in the art will appreciate that the memory
can, and typically will, comprise other components that have been
omitted for purposes of brevity. In the context of this disclosure,
a non-transitory computer-readable medium stores one or more
programs for use by or in connection with an instruction execution
system, apparatus, or device.
An electronic device network interface may comprise various
components used to transmit and/or receive data over a networked
environment via wired and/or wireless means. When such components
are embodied as an application, the one or more components may be
stored on a non-transitory computer-readable medium and executed by
the processing device.
Optionally, the system 100 can incorporate the Internet of Medical
Things (IofMT). Also known as healthcare Internet of Things, the
IofMT comprises the medical devices and applications connected to
healthcare IT systems via the internet. Wi-Fi enabled devices
facilitate machine-to-machine communication and link to cloud
platforms for data storage and management.
Referring now to FIGS. 2, 3 and 4, the hardware 200 comprises a
wearable garment 202 and at least one microwave scanner 204. Each
microwave scanner 204 is electrically coupled to electrical
components that control the microwave scanners 204. Optionally, as
shown in FIGS. 2 and 3, all of the electrical components can be
mounted/coupled to a central support. The electrical components
mounted to the support comprise the microwave switch network 207,
radiometers 208, and an electrical module 214 that comprises at
least one controller 216 and at least one data transmission device
218. The battery/power source 220 can also be coupled to the
central support.
Optionally, as shown in FIGS. 2, 3, and 4, each microwave scanner
204 can comprise a cup 201 within which, or mounted to, is a
flexible printed circuit board (FPCB) 203. Coupled to the flexible
printed circuit board 203 are the antenna modules 206. Each antenna
module 206 comprises an antenna 205 and a microwave switch 210.
Cables connect each antenna 205 to a microwave switch network 207
and/or their radiometer 208. In this application the garment 202 is
in the form of bra-like garment, and it can be made to support and
connect two microwave scanner cups 201 so that the cups 201 firmly
touch the breast skin. An electrically conductive cloth pad can be
coupled to the inside the scanner cup 201 to provide shielding from
external microwave interference sources. The electrically
conductive pad would be placed up against the user's skin when the
device 200 is worn. Optionally the cup 201 comprises at least one
piece of electrically conductive cloth. Optionally the cup 201 can
also comprise thermal insulation to provide thermal insulation from
external temperature influences. FIG. 4 is an exploded view of the
microwave scanner 204 that shows how the flexible PCB (Printed
Circuit Board) 203 can conform to the shape and size of the breast
it is being applied to. The cup 201 can either comprise two
separable halves, where the flexible PCB 203 is mounted in between
the two halves, or the flexible PCB 203 can be embedded within the
cup 201. The cup 201 can be made from a rigid material such as
plastic, but preferably the cup 201 is made from a semi-flexible
material that can conform to the shape of the user's breast it is
being applied to.
The microwave scanner ("M-S") 204 can comprise at least three
different types of configurations, depending on its application:
Type 1: M-S is a Single-Antenna Single-Channel (SASC) microwave
radiometer (aka M-R); Type 2: M-S is a
Multiple-Antenna-Single-Channel (MASC) M-R; and Type 3: M-S is a
Multiple-Antenna-Multiple-Channel (MAMC) M-R. Type 1 is essentially
a special subset of either Type 2 or Type 3. Type 3 comprises at
least one microwave switching network 207 coupling multiple antenna
modules 206 and multiple-channel radiometers 208. These different
configurations will be discussed in more detail below. All three
configurations have a cable and/or wireless interface located in
the electronics module 214 and can connect to an electronic device
302 for data link through the electronic device 302 to the main
data storage areas 304. As shown in FIG. 1, the main data storage
areas 304 are located at cloud servers that are accessible by Wi-Fi
and Internet.
FIG. 5 shows the block diagram of the microwave scanner 204 that is
coupled to the garment 202 to form the type 2 hardware device 200.
As noted above, the microwave scanner 204 comprises at least one
antenna module 206, each antenna module 206 comprising at least one
antenna 205 and at least one microwave switch 210. The antenna
modules 206 are coupled to the microwave switch network 207 via
coaxial cables. Both the microwave switch network 207 and the
radiometers are coupled to the electronics module 214, which is
itself coupled to the power source (battery) 220. The electronics
module 214 is electrically coupled to the microwave scanner 204
through the serial data link and as noted above comprises at least
one controller 216 and at least one data transmission device
218.
The antenna modules 206 receive and capture the naturally occurring
microwave thermal transmissions from the internal tissue of the
human body. The microwave scanner 204 also comprises at least one
radiometer 208, and preferably comprises a plurality of multiple
channel radiometers 208 to concurrently collect a larger amount of
thermal data to facilitate the thermal profile and signature
determination. The radiometers 208 convert the microwave thermal
energy intensity (aka thermal brightness) emitted from the tissue
that is captured by the antennas 206 into electrical energy in
terms of voltages and currents and then calibrate this electrical
energy to the temperature (thermal energy). Typically the
microwaves are emitted at millimetre-to-centimetre wavelengths,
corresponding to frequencies of 1-100 GHz range. The emissivity of
thermal radiation through specific body tissues depends on the
frequency (or wavelength). The proper selection of the frequency
band inside the microwave spectrum is crucial for the device 200 to
achieve its anticipated accuracy and sensitivity. The antennas 206
are coupled to their respective radiometers 208 by coaxial cable or
optionally by a waveguide. A waveguide is a structure that guides
waves, such as electromagnetic waves or sound waves, with minimal
loss of energy by restricting expansion to one dimension or two.
There is a similar effect in water waves constrained within a
canal, or guns that have barrels which restrict hot gas expansion
to maximize energy transfer to their bullets. Without the physical
constraint of a waveguide, wave amplitudes decrease according to
the inverse square law as they expand into three-dimensional space.
There are different types of waveguides for each type of microwave.
The original and most common is a hollow conductive metal pipe used
to carry high frequency radio waves, particularly microwaves.
As noted above, the microwave scanner 204 can comprise at least two
different configurations. The Type 2 scanner 204 can comprise
multiple antenna modules 206 with a single-channel radiometer 208
and a single multi throw microwave switch network 207 that selects
which antenna module 206 is being used. This is shown in FIGS. 5, 6
and 7. FIG. 5 shows the block diagram of the microwave scanner 204
that is coupled to the garment 202 to form the type 2 hardware
device 200. FIG. 6 shows type 1 configuration with several
single-antenna 206-single-channel radiometer 208. The Type 3
configuration comprises at least one microwave switching network
207 coupling the multiple antenna module 206 and multiple channel
radiometers 208. FIG. 7 shows a block diagram of a dual multiple
antenna single channel radiometer configuration. Measurement
samples from each antenna module 206 are collected in sequence. A
microwave switch network 207 connects each antenna 205 (within each
antenna module 206 via the microwave switch 210) to a radiometer
208 in sequence. The procedure to complete one cycle of
measurements requires several minutes because the radiometer 208 is
collecting measurements at each antenna 205 site, each of which
requiring several seconds of integrated response. A microwave
temperature reference and a reference temperature sensor 212 are
provided at each antenna module 206 location. The radiometer 208 is
effectively a Dicke type radiometer where every measurement is made
with respect to the temperature reference supplied by the
temperature sensor 212 located at each antenna module 206.
The Type 1 microwave scanner 204 (which, as noted above, is a
subset of type 2 or type 3 M-S configurations) can comprise
multiple dedicated radiometers 208, one for each antenna module
206. This configuration is shown in FIG. 6. An applicable version
of the second configuration (dual type 2) is shown in FIG. 7, where
the device 200 comprises two microwave scanners 204, one for each
breast, and each microwave scanner 204 comprises multiple antenna
modules 206 and one radiometer 208 for each breast. In this
configuration, the total measurement time is reduced because both
breasts can be scanned at the same time.
The microwave switch 210 connects each antenna 205 with its
respective radiometer 208 in sequence via the microwave switch
network 207. Optionally, the microwave switch 210 can comprise a
multi-throw microwave switch. A multi-throw microwave switch
essentially consists of combination of SPST (single-pole single
throw) switches connected to a common junction and biased so that
each switch port of the switch 210 can be enabled individually. The
common junction of the switch 210 must be designed to minimize the
resistive and reactive loading presented by the OFF ports in order
to obtain low insertion loss and VSWR (voltage standing wave ratio)
for the ON port. There are two basic methods of realizing a
multi-throw microwave switch common junction for optimum
performance over a broad frequency range. The first employs series
mounted PIN diodes connected to the common junction. A path is
selected by forward biasing its series diode and simultaneously
reverse biasing all the other diodes. This provides the desired
low-loss path for the ON port with a minimum of loading from the
OFF ports. The second method utilizes shunt mounted PIN diodes
located a quarter wavelength from the junction. The diode(s) of the
selected ON port is reverse biased while the OFF ports are forward
biased to create a short circuit across the transmission line. As a
result of the quarter wavelength spacing, the short circuits are
transformed to open circuits at the junction. By proper choice of
transmission line impedances and minimization of stray reactance it
is possible to construct a switch of this type with low insertion
loss and VSWR over a three to one bandwidth. VSWR is defined for
the input and output ports of the selected ON path. Similar switch
configurations using FET devices instead of PIN diodes are often
used for microwave switches like these.
Preferably, at least one temperature sensor 212 is located at each
antenna module 206 site such that the number of antennas 205 the
device 200 has will be equal to the number of temperature sensors
212 the system has. However, while this ratio for temperature
sensors 212 to antennas 205 is not absolutely necessary, it is
preferred for optimal detection of warmer tissue areas. The
temperature sensors 212 provide a reference temperature reading of
the surrounding environment (via the microwave termination
connected to the switch 210) for comparison with the temperature
reading obtained by accompanying antenna 205 to determine the
temperature of the tissue within the field of view of the antenna.
The difference between the reading of the temperature sensor 212
and the reading of the accompanying antenna 205, gives the
temperature of the tissue within a volume of tissue under the
antenna when added to the reference temperature reading.
The at least one controller 216 is located within the electronics
module 214 and is configured to command the microwave switch
network 207 switching sequence for radiometer 208 and the sequence
of the temperature sensor 212 measurements and to collect both the
radiometer 208 microwave measurements as well as the temperature
sensor 212 measurements. The controller 216 is electrically coupled
to each microwave scanner 204. Optionally the device 200 can have
more than one controller 216.
The at least one data transmission device 218 is also located
within the electronics module 214 and is electrically coupled to
each scanner 204. Data transmission (also data communication or
digital communications) is the transfer of data (a digital bit
stream or a digitized analog signal) over a point-to-point or
point-to-multipoint communication channel. Examples of such
channels are copper wires, optical fibers, wireless (including
microwave, optical and laser) communication channels, storage media
and computer buses. As noted above, the data transmission device
218 transmits the measurement data collected by the controller 216
from the radiometers 208 and the temperature sensors 212 either to
an electronic device 302, or directly to the data cloud storage
304. The measurement data can be wirelessly transmitted as an
electromagnetic signal, such as an electrical voltage, radio wave,
microwave, or infrared signal.
Optionally, the wireless communication technology can comprise
Wi-Fi Direct, which was initially called Wi-Fi P2P (Peer to Peer).
Wi-Fi Direct is a Wi-Fi standard that enables devices to easily
connect with each other without requiring a wireless access point.
Wi-Fi Direct allows two devices to establish a direct Wi-Fi
connection without requiring a wireless router. Hence, Wi-Fi Direct
is a single radio hop communication, not a multi-hop wireless
communication, unlike wireless ad hoc networks and mobile ad hoc
networks. Wi-Fi ad hoc mode, however, supports multi-hop radio
communications, with intermediate Wi-Fi nodes as packet relays.
One advantage of Wi-Fi Direct is the ability to connect devices
even if they are from different manufacturers. Only one of the
Wi-Fi devices needs to be compliant with Wi-Fi Direct to establish
a peer-to-peer connection that transfers data directly between them
with greatly reduced setup.
Wi-Fi Direct negotiates the link with a Wi-Fi Protected Setup
system that assigns each device a limited wireless access point.
The "pairing" of Wi-Fi Direct devices can be set up to require the
proximity of a near field communication, a UHF radio wave signal,
or a button press on one or all the devices.
Once the measurement data arrives at the electronic device 302, the
device 302 uploads the data to the cloud data storage 304. A
service provider collects and processes the data from the cloud
storage 304. Several algorithms and software, respectively,
generate the thermogram images, perform image classifications,
analyze the data and make the determination of suspicious sites,
provide suitable feedback and analyze the results for the user and
healthcare practitioner (physician) through the cloud distribution.
Machine Deep Learning models and algorithms are applied to
accommodate the growing body of data to enhance the thermal image
classification algorithm accuracy.
Optionally, as noted above, the data can be transmitted directly to
the cloud data storage 304 from the device 200. In this embodiment,
the health practitioner can then access the uploaded data (and
optionally processed data) via an electronic device 302 that is
communicatively coupled (usually via wireless transmission means
although it could be via wired means as well) to the cloud data
storage 304.
The power source 220 can either be a power cord for coupling the
garment 202 (and its scanners 204) to an electrical socket, or the
power source module 220 can be a rechargeable battery coupled to
battery charging and indicating circuitry or located within the
electrical module 214. Optionally, the battery is rechargeable,
either by wired or wirelessly recharging means, such as charging
pads, charging bowls, or uncoupled radio frequency.
Charging pads typically use tightly-coupled electromagnetic
inductive or non-radiative charging. Charging bowls or
through-surface type chargers typically use loosely-coupled or
radiative electromagnetic resonant charging that can transmit a
charge a few centimeters. Uncoupled radio frequency (RF) wireless
charging allows a trickle charging capability at distances of many
feet.
Both tightly coupled inductive and loosely-coupled resonant
charging operate on the same principle of physics: a time-varying
magnetic field induces a current in a closed loop of wire.
Optionally, clip charging could be used where a clip is clipped
onto the electronics module 214 to charge it (rather than the
traditional wired method).
Optionally, the garment 202 can have both wired and wireless
charging abilities.
The garment 202 has several advantages. First, it ensures stable
and firm contact of the antennas 205 with the breast over the
several minutes required to complete the measurement process.
Second, it ensures accurate antenna 205 placement at the specified
sites during subsequent measurements enabling temperature history
comparisons for the purpose of long term monitoring and tracking.
Third, the garment 202 provides for a comfortable measurement
procedure for the users (both healthy and sick patients) and a much
less tedious procedure for the instrument operator as compared to a
single antenna/multiple antenna placement device. Fourth, the
measurement could be self-administered, meaning the users could
administer the testing in the privacy of their own home, rather
than having to visit a clinic for testing. And fifth, it provides
better microwave and thermal interference shielding against the
external environment during the measurement process.
The use and function of all of the components will now be described
in detail. As noted above, the microwave scanner 204 uses microwave
radiometry to sense temperatures beneath the skin. The objective is
to detect elevated temperatures of breast tissue resulting from
increasing metabolic activity and the angiogenesis process that
induces a temperature increase around a cancer cell region. The
microwave scanner 204 compares the temperatures from multiple
measurement sites to identify a suspicious warm spot in the area.
Thermography using other "heat" sensing techniques, such as
infrared, has been proposed for this purpose in the past. However,
the advantage of a microwave scanner 204 of the present invention
as compared to previously proposed approaches is that the microwave
scanner 204 can measure the subsurface (subcutaneous) tissue
temperatures which cannot be measured using other sensing devices.
The availability of subcutaneous tissue temperature, which is a
pathological and physiological biomarker, enables the potential
early detection of cancer and its subsequent diagnosis.
As noted above, the microwave scanner 204 can comprise multiple
antennas 205 and multiple-channel radiometer 208 with antennas in
contact with the skin to measure subcutaneous (subsurface)
temperatures at multiple sites on the body. The antennas
205/antenna modules 206 are arrayed in a specific holder, such as
the cup 201 coupled with bra-shaped garment 202 shown in FIGS. 1
and 2. As discussed above, FIG. 8 shows a block diagram of one
antenna module 206. The antenna module 206 uses a single pole
triple throw (SP3T) switch 210 to connect between the antenna 205
and two reference termination resistors. In normal temperature
measurement mode, the switch 210 toggles between the antenna 205
and one of the reference termination resistors to produce the
temperature difference reading between the breast tissue and the
reference termination temperature sensor 212. In calibration mode,
which is discussed in greater detail below, the switch 210 toggles
between the two termination resistors, both of which are at the
indicated temperature sensor. Being at the same temperature, the
difference measurement should be zero. Any measured temperature
other than zero is an error in the measurement path which will also
be present in the normal measurement mode. The calibration
temperature difference is read and then subtracted from the tissue
temperature measurement to make the correction.
As noted above, the device 200 of the present invention uses
microwave thermography to map temperature in tissue (breasts in
this instance) in order to locate possible cancer tumor sites. In
order for the device 200 to determine tissue temperature
accurately, it is necessary to calibrate the microwave path between
each antenna 205 and radiometer(s) 208. These paths can include
lengths of coaxial cable and multi-throw microwave switches. The
path to each antenna 205 from radiometer 208 will have different
characteristics. The device 200 measures the temperature difference
between the breast tissue within the antenna 205 field of view
(FOV) and a reference termination resistor of known temperature
located adjacent to the antenna 205. A microwave switch 210 in the
antenna module 206 toggles between the antenna 205 and the
reference termination resistor to make the temperature difference
measurement. This temperature difference is added to the known
reference termination temperature to provide the absolute
temperature of the tissue under each antenna 205. In practice,
conductor (coaxial cable) losses and small irregularities in the
microwave path will produce measurement errors. These
irregularities can cause offset error where the measured
temperature is offset from the true tissue temperature by an
unknown but fixed amount. The error can also be in the form of a
gain error where the measured temperature is related to the
magnitude of the temperature difference. The device 200 is
configured with a method of determining and removing these
measurement errors just prior to breast temperature measurement
such that a correction for this type of measurement error can be
made at each antenna module 206 site under the exact conditions of
the measurement.
The gain error is determined using the schematic shown in FIG. 9. A
microwave noise source 900 is coupled onto the radiometer 208 at
the radiometer input 910. FIG. 9 shows this coupling through a
microwave circulator 912 but a directional coupler can also be
used. Noise power propagates out through the radiometer input 910
connector toward the antenna module 206. This noise power is
modulated in synchronization with the radiometer 208 detector
clock. The antenna switch 210 is set to an open circuit position.
The open circuit position exists when none of the three input legs
is selected. Alternately, a four throw switch could be used and a
short or open circuit attached to the selected fourth leg. The
radiometer 208 measures the magnitude of the noise power reflected
by the switch 210 in the open position and compares this value to
the noise power measured when a switch internal to the radiometer
208 is set to a short circuit position. The ratio of the reflected
power measured from the antenna switch 210 and the reflected power
measured from the internal switch is twice the path loss between
the radiometer 208 and the antenna module 206. The magnitude of the
temperature measurement is then corrected for this path loss.
Also as noted above, in one aspect, the present invention comprises
a method of detecting disease. The method is shown in FIG. 10 and
comprises the steps of:
a) providing the device 200;
b) applying the device 200 to a user;
c) either manually or automatically, scanning the user's tissue
with the microwave scanner 204 of the device 200 such that a
plurality of temperature readings are taken by the antennas 205 and
the temperature sensors 212;
d) after completing one cycle of measurements which takes place in
step c), transmitting the plurality of temperature readings from
the device 200 to an electronic device 302;
e) after step d) transmitting the plurality of temperature readings
from the electronic device 302 to a cloud data storage 304; and
f) processing the plurality of temperature readings to determine
suspicious sites.
Optionally, the processing in step f) can comprise generating at
least one thermogram image and analyzing the processed data to
determine and to classify suspicious areas.
Optionally, the device 200 can be applied by the users to
themselves in the privacy of their own home. Then a physician can
access the processed data via the cloud data storage 304 and
provide guidance regarding same. This guidance can comprise a
disease diagnosis which can be provided to the user via the
internet to complete the process of tele-healthcare cycle.
Optionally, the method of detecting disease comprises the steps
of:
a) receiving on an electronic device 302 from the device 200 a
plurality of temperature readings taken by a plurality of antennas
206 and a plurality of temperature sensors 212;
b) transmitting the plurality of temperature readings from the
electronic device 302 to a cloud data storage 304; and
c) processing the plurality of temperature readings to determine
suspicious sites.
Optionally, the present invention comprises a method of using the
device 200 of the present invention. The method is shown in FIG. 11
and comprises the steps of:
a) providing the device 200;
b) applying the device 200 to a user;
c) scanning the user's tissue with the microwave scanner 204 of the
device 200 such that a plurality of temperature readings are taken
by the radiometer 208 by toggling the switch 210 to the antennas
205 and the temperature sensors 212;
d) transmitting the plurality of temperature readings to an
electronic device 302;
e) transmitting the plurality of temperature readings from the
electronic device 302 to a cloud data storage 304.
Optionally, the method of using the device 200 further comprises
step f) processing the plurality of temperature readings to
determine suspicious areas.
Optionally, the device 200 can be applied by the patient to
themselves in the privacy of their own home. A physician can access
the processed data via the cloud data storage 304 and provide
guidance regarding same.
An additional method of using the device 200 of the present
invention comprises the steps of:
a) receiving on an electronic device 304 from a device 200 a
plurality of temperature readings taken by a plurality of antennas
206 and a plurality of temperature sensors 212;
b) transmitting the plurality of temperature readings from the
electronic device 302 is 58 to 74 to a cloud data storage 304;
and
c) processing the plurality of temperature readings to determine
suspicious sites.
The breast cancer life cycle is depicted in FIG. 12. It consists of
three phases: Phase (1) Pre-clinic phase--0 to 8 years after cancer
cell mutations. Phase (2) Clinic phase--8 to 12 years after
mutations; and Phase (3), Post-clinic phase--12 years after
mutations. As an example of the various applications of the system
100 and device 200 of the present invention, it should be noted
that the application and use of the system 100 and device 200 is
different during the different phases of the cancer life cycle:
(1) During the pre-clinical phase, the user group is focusing on
the women (and men) who are at the most risk for breast cancer. The
primary objective is to continuously monitor and track the internal
thermal profile variations to detect any thermal abnormalities
caused by cancer, inflammation or other sickness.
(2) During the clinic phase, the user group includes medical
professionals, such as physicians, nurses and other medical staff,
as well as patients.
The device 200 can be used for breast cancer screening for women
who have dense breast tissue and/or have micro-calcifications to
supplement/compliment the deficiencies of both mammography (X-ray)
devices (which have low sensitivity for dense breast tissue) and
ultra-sonography (ultrasound) devices (that cannot distinguish
between micro-calcification tissue from tumor cysts). In addition,
the device 200 provides the thermal (temperature) data and
information to assist physicians (and/or breast surgeons) to
monitor the effectiveness and efficacy of their services, such as
treatments of cancers. The device 200 provides thermal
(temperature) data that can also assist the pathologist to more
accurately differentiate the malignant tumor from benign tumor.
(3) During the post-clinical phase, the device 200 can provide
early warning of cancer recurrence and metastases based on the
continuous monitoring of thermal (temperature) abnormalities in the
tissue of former cancer patients.
As noted above, one aspect of the present invention is implemented
as a program, application, or product for use with a computer
system and the device 200 of the present invention. The program(s)
of the program product defines functions of the embodiments
(including the methods and techniques described herein) and can be
contained on a variety of computer-readable storage media.
Illustrative computer-readable storage media include, but are not
limited to: (i) non-writable storage media (e.g., read-only memory
devices within a computer such as CD-ROM disks readable by a CD-ROM
drive) on which information is permanently stored; and (ii)
writable storage media (e.g., floppy disks within a diskette drive
or hard-disk drive) on which alterable information is stored. Such
computer-readable storage media, when carrying computer-readable
instructions that direct the functions of the present invention,
are embodiments of the present invention. Other media include
communications media through which information is conveyed to a
computer, such as through a computer or telephone network,
including wireless communications networks. The latter embodiment
specifically includes transmitting information to/from the Internet
and other networks. Such communications media, when carrying
computer-readable instructions that direct the functions of the
present invention, are embodiments of the present invention.
Broadly, computer-readable storage media and communications media
may be referred to herein as computer-readable media.
The required APPs for IoMT connectivity are performing four basic
functions to integrate the three segments into the system 100 as
follows:
1) Hand shaking and data streaming between the mobile device with
either Android or iOS and other mobile device platforms and
microwave scanner:
2) Two-way data linking between mobile device and cloud server (or
other type of big data base storage).
3) Raw data downloading and processed data, including graphics and
images, uploading between cloud server storage and data analysis
and processing station.
4) Processed data downloading and medical assessments and diagnosis
message uploading between medical centers/hospital and cloud
server.
Advantages of the Present Invention
The system 100 of the present invention can provide telemedicine
and virtual clinic healthcare services for breast wellness and
illness screening, include but not limited to, cancer prognosis and
diagnosis. The screening can be done without any invasive
procedures. The patient simply puts the garment 202 and scanner
cups 201 on, the microwave scanner 204 is activated, and a
plurality of temperature readings are taken. If any abnormal "hot
spots" are noted in the tissue, the supervising physician now has
an idea of exactly where to focus and perform any additional
diagnostic techniques.
For sick persons and cancer patients--Due to the wireless data
transmission capabilities of the system 100 and the portable nature
of the device 200, the patient can administer the testing in the
privacy of their own home or place, such as a hotel room, rather
than having to visit a clinic or hospital. This saves the patient
both time and money.
For physicians--the system 100 can increase the clinical efficiency
by shortening clinic time as well as providing additional, valuable
information from the processed image/data results of each patient's
virtual visit. The system 100 can also extend the physician's
patients geographical distributions.
For hospitals & clinic centers--the system 100 can reduce the
patient visit frequency and hence decrease administrative load
(cost saving for hospitals). The system 100 can also provide a
better healthcare environment attributed to lessened traffic flow
in hospital facilities.
Other applications of the present invention:
With the unique configuration of the microwave scanner 204, it can
sense and measure the subcutaneous internal heat power density in
terms of so-called radiometric temperature. Availability of
subcutaneous radiometric temperature opens up a wide variety of
medical applications that include, but are not limited to:
(1) detection of internal organ cancerous cells and abnormal
tissues, such as cancers of the breast, lung, liver, pancreas, and
ovary;
(2) identification of internal infection and/or inflammatory
regions, such as arthritis, thyroid disease, and diagnosis of
maxillary sinusitis;
(3) assistance with birth control;
4) providing thermogram images and temperature information to
assist in the therapeutic treatment of disease, such as
chiropractic thermal treatment, active microwave thermotherapy and
ablation cancer therapy that require precise temperature control,
as well as enhancement of the efficacy of acupuncture treatment;
and
(5) the radiometric temperature can be used to differentiate the
malignant cancer cells from the benign cancer cells, and the
thermal data can be used to increase biopsy accuracy and help to
determine whether the biopsy is even necessary in the first
place.
Although the present invention has been described in considerable
detail with reference to certain preferred embodiments, other
embodiments are possible. The steps disclosed for the present
methods, for example, are not intended to be limiting nor are they
intended to indicate that each step is necessarily essential to the
method, but instead are exemplary steps only. Therefore, the scope
of the appended claims should not be limited to the description of
preferred embodiments contained in this disclosure. All references
cited herein are incorporated by reference in their entirety.
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